• International Regulatory Strategy for compliance with Medical Devices Directives, FDA and global regulatory requirements
• Quality Systems development to meet European, US and International standards ( ISO 9001 / ISO 13485 / FDA Quality System Regulation)
• Project management and technical services for new product development and design transfer to manufacture
• Market research, identification of business partners, preparation and review of business and marketing plans

Based near Cambridge, England, we can help bring your product to market and comply with regulatory requirements. Follow the links on the left to learn more of what we offer, or contact us today to discuss your requirements.

Revised Medical Devices Directive